1.Methodology for Developing Patient Guideline (3):Reporting Frameworks and Presentation
Lijiao YAN ; Ning LIANG ; Haili ZHANG ; Nannan SHI ; Ziyu TIAN ; Ruixiang WANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Yingfeng ZHOU ; Dan YANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(22):2304-2309
Standardized reporting is a crucial factor affecting the use of patient guidelines (PGs), particularly in the reporting and presentation of recommendations. This paper introduced the current status of PG reporting, including the research on PG content and presentation formats, and provided comprehensive recommendations for PG reporting from aspects such as overall framework, recommendations, presentation format, and readability. First, the presentation of PG recommendations should include clearly defined clinical questions, recommendations and their rationale, and guidance on how patients should implement the interventions; for specific content in the PG, such as level of evidence, level of recommendation, it is recommended to explain in text the reasons for giving different levels of recommendation, i.e., to present the logic behind giving the level of recommendation to the patient; additional information needed in the recommendation framework should be supplemented by tracing references or authoritative textbooks and literature that support the recommendations. Subsequently, the PG text should be written based on the Reporting Checklist for Public Versions of Guidelines (RIGHT-PVG) reporting framework. Finally, to enhance readability and comprehension, it is recommended to refer to the Patient Education Materials Assessment Tool (PEMAT) for translating PG content. To enhance the readability of PGs, it is suggested to present the PG content in a persona-lized and layered manner.
2.Methodology for Developing Patient Guideline (2):Process and Methodology
Lijiao YAN ; Ning LIANG ; Nannan SHI ; Sihong YANG ; Ziyu TIAN ; Dan YANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Ruixiang WANG ; Yingfeng ZHOU ; Shibing LIANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(21):2194-2198
At present, the process and methodology of patient guidelines (PGs) development varies greatly and lacks systematic and standardised guidance. In addition to the interviews with PG developers, we have sorted out the relevant methodology for the adaptation and development of existing clinical practice guideline recommendations and facilitated expert deliberations to achieve a consensus, so as to finally put forward a proposal for guidance on the process and methodology for the development of PGs. The development of PGs can be divided into the preparation stage, the construction stage, and the completion stage in general, but the specific steps vary according to the different modes of development of PGs. The development process of Model 1 is basically the same as the patient version of the guideline development process provided by the International Guidelines Network, i.e., team formation, screening of recommendations, guideline drafing, user testing and feedback, approval and dissemination. The developer should also first determine the need for and scope of translating the clinical practice guideline into a patient version during the preparation phase. Model 2 adds user experience and feedback to the conventional clinical practice guideline development process (forming a team, determining the scope of the PG, searching, evaluating and integrating evidence, forming recommendations, writing the guideline, and expert review). Based on the different models, we sort out the process and methods of PG development and introduce the specific methods of PG development, including how to identify the clinical problem and how to form recommendations based on the existing clinical practice guidelines, with a view to providing reference for guideline developers and related researchers.
3.Assessment of risk factors for bronchopulmonary dysplasia with pulmonary hypertension and construction of a prediction nomogram model.
Shu Zhen DAI ; Shu Shu LI ; Mei Yun ZHOU ; Yan XU ; Lin ZHANG ; Yu Han ZHANG ; Dan Ni YE ; Li Ping XU ; Shu Ping HAN
Chinese Journal of Pediatrics 2023;61(10):902-909
Objective: To explore the risk factors of pulmonary hypertension (PH) in premature infants with bronchopulmonary dysplasia (BPD), and to establish a prediction model for early PH. Methods: This was a retrospective cohort study. Data of 777 BPD preterm infants with the gestational age of <32 weeks were collected from 7 collaborative units of the Su Xinyun Neonatal Perinatal Collaboration Network platform in Jiangsu Province from January 2019 to December 2022. The subjects were randomly divided into a training cohort and a validation cohort at a ratio of 8∶2 by computer, and non-parametric test or χ2 test was used to examine the differences between the two retrospective cohorts. Univariate Logistic regression and multivariate logistic regression analyses were used in the training cohort to screen the risk factors affecting the PH associated with BPD. A nomogram model was constructed based on the severity of BPD and its risk factors,which was internally validated by the Bootstrap method. Finally, the differential, calibration and clinical applicability of the prediction model were evaluated using the training and verification queues. Results: A total of 130 among the 777 preterm infants with BPD had PH, with an incidence of 16.7%, and the gestational age was 28.7 (27.7, 30.0) weeks, including 454 males (58.4%) and 323 females (41.6%). There were 622 preterm infants in the training cohort, including 105 preterm infants in the PH group. A total of 155 patients were enrolled in the verification cohort, including 25 patients in the PH group. Multivariate Logistic regression analysis revealed that low 5 min Apgar score (OR=0.87, 95%CI 0.76-0.99), cesarean section (OR=1.97, 95%CI 1.13-3.43), small for gestational age (OR=9.30, 95%CI 4.30-20.13), hemodynamically significant patent ductus arteriosus (hsPDA) (OR=4.49, 95%CI 2.58-7.80), late-onset sepsis (LOS) (OR=3.52, 95%CI 1.94-6.38), and ventilator-associated pneumonia (VAP) (OR=8.67, 95%CI 3.98-18.91) were all independent risk factors for PH (all P<0.05). The independent risk factors and the severity of BPD were combined to construct a nomogram map model. The area under the receiver operating characteristic (ROC) curve of the nomogram model in the training cohort and the validation cohort were 0.83 (95%CI 0.79-0.88) and 0.87 (95%CI 0.79-0.95), respectively, and the calibration curve was close to the ideal diagonal. Conclusions: Risk of PH with BPD increases in preterm infants with low 5 minute Apgar score, cesarean section, small for gestational age, hamodynamically significant patent ductus arteriosus, late-onset sepsis, and ventilator-associated pneumonia. This nomogram model serves as a useful tool for predicting the risk of PH with BPD in premature infants, which may facilitate individualized early intervention.
Infant
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Male
;
Infant, Newborn
;
Humans
;
Pregnancy
;
Female
;
Bronchopulmonary Dysplasia/epidemiology*
;
Infant, Premature
;
Hypertension, Pulmonary/epidemiology*
;
Retrospective Studies
;
Nomograms
;
Ductus Arteriosus, Patent/epidemiology*
;
Pneumonia, Ventilator-Associated/complications*
;
Cesarean Section/adverse effects*
;
Gestational Age
;
Risk Factors
;
Sepsis
4.Characteristics and clinical significance of mitochondrial injury of T lymphocyte subsets in patients with autoimmune hepatitis
Wuyin WU ; Dan XIONG ; Dongfang NI ; Yijun ZHOU ; Zhaoyi LI
Chinese Journal of Postgraduates of Medicine 2023;46(3):247-251
Objective:To study the characteristics and clinical significance of mitochondrial injury of T lymphocyte subsets in patients with autoimmune hepatitis (AIH).Methods:The clinical data of 57 patients with AIH (AIH group) from June to December 2021 in Hangzhou Xixi Hospital were retrospectively analyzed, while 60 healthy physical examiners were included as healthy group. The peripheral blood T lymphocyte subsets (CD 8+ T lymphocyte count and CD 4+ T lymphocyte count) were detected by flow cytometry, and matched mitochondrial staining value according to certain algorithm was used to determine the mitochondrial damage of helper T lymphocyte (Th cell) and suppressor T lymphocyte (Ts cell). The levels of IgG, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were measured using a Roche E170 automatic electrochemiluminescence immunoassay. Anti-nuclear antibody (ANA) titer was measured by immunofluorescence. Multivariate Logistic regression was used to analyze the independent risk factors of mitochondrial damage of Th cell and Ts cell in patients with AIH. Results:The ALT, AST, IgG, positive rate of ANA titer, CD 4+ T lymphocyte count, CD 8+ T lymphocyte count, rate of Th cell mitochondrial injury and rate of Ts cell mitochondrial injury in AIH group were significantly higher than those in healthy group: (118.90 ± 37.61) U/L vs. (30.96 ± 14.37) U/L, (102.40 ± 36.51) U/L vs. (31.12 ± 14.06) U/L, (18.40 ± 3.71) g/L vs. (13.89 ± 1.98) g/L, 96.49% (55/57) vs. 16.67% (10/60), 438 (323, 637) × 10 6/L vs. 398 (272, 469) × 10 6/L, 296 (211, 296) × 10 6/L vs. 270 (193, 322) × 10 6/L, 61.40% (35/57) vs. 8.33% (5/60) and 82.46% (47/57) vs. 11.67% (7/60), and there were statistical differences ( P<0.01 or <0.05). Multivariate Logistic regression analysis result showed that the AST elevated and CD 8+ T lymphocyte count reduced were the independent risk factors of Ts cell mitochondrial injury in patients with AIH ( OR = 1.06 and 0.99, 95% CI 1.01 to 1.10 and 0.99 to 1.00, P<0.05); the ALT elevated and IgG elevated were the independent risk factors of Th cell mitochondrial injury in patients with AIH ( OR = 1.08 and 1.66, 95% CI 1.02 to 1.14 and 1.11 to 2.48, P<0.05). Conclusions:It is of positive clinical significance to measure the T lymphocyte subtype mitochondrial injury in patients with AIH. The probability of mitochondrial injury of T lymphocyte subtype can be predicted by biochemical indexes such as ALT, AST and IgG, so as to indirectly evaluate the liver cell necrosis.
5.Sperm-specific protein ACTL7A as a biomarker for fertilization outcomes of assisted reproductive technology.
Tian-Ying YANG ; Ying CHEN ; Guo-Wu CHEN ; Yi-Si SUN ; Zhi-Chao LI ; Xiao-Rong SHEN ; Yi-Ni ZHANG ; Wen HE ; Dan ZHOU ; Hui-Juan SHI ; Ai-Jie XIN ; Xiao-Xi SUN
Asian Journal of Andrology 2022;24(3):260-265
Obtaining high-quality embryos is one of the key factors to improve the clinical pregnancy rate of assisted reproductive technologies (ART). So far, the clinical evaluation of embryo quality depends on embryo morphology. However, the clinical pregnancy rate is still low. Therefore, new indicators are needed to further improve the evaluation of embryo quality. Several studies have shown that the decrease of sperm-specific protein actin-like 7A (ACTL7A) leaded to low fertilization rate, poor embryo development, and even infertility. The aim of this study was to study whether the different expression levels of ACTL7A on sperm can be used as a biomarker for predicting embryo quality. In this study, excluding the factors of severe female infertility, a total of 281 sperm samples were collected to compare the ACTL7A expression levels of sperms with high and low effective embryo rates and analyze the correlation between protein levels and in-vitro fertilization (IVF) laboratory outcomes. Our results indicated that the ACTL7A levels were significantly reduced in sperm samples presenting poor embryo quality. Furthermore, the protein levels showed a significant correlation with fertilization outcomes of ART. ACTL7A has the potential to be a biomarker for predicting success rate of fertilization and effective embryo and the possibility of embryo arrest. In conclusion, sperm-specific protein ACTL7A has a strong correlation with IVF laboratory outcomes and plays important roles in fertilization and embryo development.
Biomarkers/metabolism*
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Female
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Fertilization
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Fertilization in Vitro
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Humans
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Male
;
Pregnancy
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Pregnancy Rate
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Reproductive Techniques, Assisted
;
Spermatozoa/metabolism*
6.Independent and joint effect of chronotype and sleep duration on self-rated health in medical students.
Pan DING ; Jin Yong LI ; Xiao Li YE ; Xiao Han YIN ; Dan Ni QIAN ; Chong Zhou ZHONG ; Hong Ying SHI
Chinese Journal of Epidemiology 2022;43(11):1796-1803
Objective: To investigate the independent and joint effects of chronotype and sleep duration on self-rated health in medical students. Methods: A cross-sectional study was conducted in 1 526 medical students selected through proportional stratified cluster random sampling from a medical university in Zhejiang province. A questionnaire survey was conducted to collect the information about their basic demographic characteristics, chronotype, sleep duration, and other lifestyle factors such as midnight snack, sedentary behavior, physical activity, meal time, and self-rated health. The independent and joint effects of chronotype and sleep duration on self-rated health were assessed by logistic regression model after controlling for confounding variables. Results: The numbers of the students with evening chronotype, neutral chronotype, and morning chronotype were 664 (43.5%), 442 (29.0%), and 420 (27.5%), respectively. Among the medical students, 42.8% (653) had poor self-rated health. Compared with those with the morning chronotype, the adjusted ORs for those with neutral chronotype and evening chronotype were 1.69 (95%CI: 1.23-2.31) and 2.43 (95%CI: 1.81-3.26), respectively, trend test P<0.001. Compared with those with sleep duration of 8 h or above per night, the adjusted ORs for those with sleep duration of 7 and ≤6 h per night were 1.40 (95%CI: 1.07-1.84) and 2.38 (95%CI: 1.69-3.37), respectively, trend test P<0.001. In the joint effect, compared with those with the morning chronotype and sleep duration of 8 h or above per night, the adjusted OR for those with evening chronotype and sleep duration of ≤6 h per night was 6.53 (95%CI: 3.53-12.09). Conclusions: Both evening chronotype and insufficient sleep were associated with increased odds of poor self-rated health in medical students, and they had joint effects. Therefore, it is necessary to promote early to bed, early to rise and adequate sleep in medical student to maintain their health.
Humans
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Students, Medical
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Cross-Sectional Studies
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Sedentary Behavior
;
Sleep
7.Clinical outcome of single posterior implant-supported monolithic zirconia crowns fabricated using full digital workflow and conventional workflow: a 3-year follow-up.
Sheng Han GAO ; Dan Ni GUO ; Yong Sheng ZHOU ; Shao Xia PAN
Chinese Journal of Stomatology 2022;57(3):272-279
Objective: To compare the clinical performance of posterior single implant-supported monolithic zirconia crowns fabricated by full digital workflow and that of those fabricated by conventional workflow. Methods: This is prospective clinical research. Thirty-five patients who participated in a previous study during August 2017 to October 2018 at Department of Prosthodontics, Peking University School and Hospital of Stomatology were included in this 3-year follow-up study. The 35 patients, 17 females and 18 males, aged (49.0±15.4) years (24-86 years old), was allocated into two groups. In the full digital workflow group, intraoral scanning was taken immediately after implant placement, and a full zirconia implant crown was fabricated using model-free computer aided design/computer aided manufacturing (CAD/CAM) procedure (n=14). In the conventional group, a conventional impression was taken 3 months after implant placement and the stone model was produced. A full zirconia implant crown was fabricated using conventional model-based procedure (n=21). Three years following crown delivery, all the prostheses were evaluated in the aspect of color, surface roughness, contour and marginal integrity using modified US Public Health Service criteria (MUSPHS criteria). The soft and hard tissue around implant was evaluated using modified plaque index, probing depth (PD), number of implants with bleeding on probing, marginal bone loss (MBL). The biological and mechanical complication were also recorded. Statistical analysis was performed using independent samples t test, Mann-Whitney U test and Fisher's exact test. Results: The total survival rate of prosthesis and implant was 100% (35/35). No significant difference in MUSPHS criteria ratings on color, surface roughness, contour and marginal integrity of these crowns were found between the full digital workflow group and the conventional group (P>0.05). Sixteen out of the 35 crowns had a contour score of B due to loss of interproximal contact. Ten out of the 35 crowns had the screw hole sealing resin sinking or falling off, four in the full digital workflow group and six in the conventional group. There was no significant difference in the rate of prostheses mechanical complications between the two groups (P=1.000). For all the implants, there was no significant difference in MBL, PD, the modified plaque index, and number of implants with bleeding on probing between the two groups (U=119.50,133.00,142.50, t=-0.53, P>0.05). Conclusions: The clinical performance of implant-supported posterior single monolithic zirconia crowns fabricated by full digital workflow was stable. There was no significant difference in the clinical performance of the single implant crowns between the full digital workflow group and the conventional group.
Adult
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Aged
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Aged, 80 and over
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Crowns
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Female
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Follow-Up Studies
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Humans
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Male
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Middle Aged
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Prospective Studies
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United States
;
Workflow
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Young Adult
;
Zirconium
8.Research Progress on Animal Models of Menopausal Syndrome: A Review
Dan-ni ZHOU ; Ruo-nan WEI ; Meng-jiao KANG ; Jia CHEN ; Lin-hua ZHAO ; Wei ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(18):243-250
In order to explore the pathological mechanism of perimenopausal syndrome and seek prevention and treatment measures, it is necessary to establish animal models that similar to human perimenopausal syndrome, so as to provide reference for drug research, new drug development and clinical application. In this paper, the keywords of "perimenopausal period" "perimenopausal syndrome" "menopause" "menopausal syndrome""menopausal period" "menopausal syndrome" and "animal" were searched in China National Knowledge Infrastructure (CNKI), Chongqing Weipu, China Biomedical Literature Database (CBM) and Pubmed. In addition, the selection of domestic peripheral menopausal syndrome model animals in recent years and the advantages and disadvantages of corresponding models were summarized. A total of 673 studies were identified, of which 61 were included in the analysis. The most common animal model of perimenopausal syndrome is castration model, while the immunodeficiency model is less used. With the aging of the population and the rapid increase of psychosocial stress, the incidence of perimenopausal syndrome is high. Therefore, it is particularly important to explore the mechanism of perimenopausal syndrome. According to the experimental purpose, experimental period, experimental technology and other factors, the selection of appropriate model animals and modeling methods is the key of the success of the experiment of perimenopausal syndrome.
9.Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial.
Li NI ; Zheng WEN ; Xiaowen HU ; Wei TANG ; Haisheng WANG ; Ling ZHOU ; Lujin WU ; Hong WANG ; Chang XU ; Xizhen XU ; Zhichao XIAO ; Zongzhe LI ; Chene LI ; Yujian LIU ; Jialin DUAN ; Chen CHEN ; Dan LI ; Runhua ZHANG ; Jinliang LI ; Yongxiang YI ; Wei HUANG ; Yanyan CHEN ; Jianping ZHAO ; Jianping ZUO ; Jianping WENG ; Hualiang JIANG ; Dao Wen WANG
Frontiers of Medicine 2021;15(5):704-717
We conducted a randomized, open-label, parallel-controlled, multicenter trial on the use of Shuanghuanglian (SHL), a traditional Chinese patent medicine, in treating cases of COVID-19. A total of 176 patients received SHL by three doses (56 in low dose, 61 in middle dose, and 59 in high dose) in addition to standard care. The control group was composed of 59 patients who received standard therapy alone. Treatment with SHL was not associated with a difference from standard care in the time to disease recovery. Patients with 14-day SHL treatment had significantly higher rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests than the patients from the control group (93.4% vs. 73.9%, P = 0.006). Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), -46.39 (-86.83 to -5.94) HU; P = 0.025) and day 14 (mean difference (95% CI), -74.21 (-133.35 to -15.08) HU; P = 0.014). No serious adverse events occurred in the SHL groups. This study illustrated that SHL in combination with standard care was safe and partially effective for the treatment of COVID-19.
COVID-19
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Humans
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Medicine, Chinese Traditional
;
Research
;
SARS-CoV-2
;
Treatment Outcome
10.The roles of two HIV self-testing models in promoting HIV-testing among men who have sex with men
Yi ZHOU ; Dan WU ; Weiming TANG ; Xiaofeng LI ; Shanzi HUANG ; Yawei LIU ; Xi HE ; Ying LU ; Yuxin NI ; Jiarun LI ; Wencan DAI
Chinese Journal of Epidemiology 2021;42(2):263-268
Objective:To evaluate the roles between two different HIV self-testing models in promoting HIV-testing among men who have sex with men (MSM).Methods:This paper focuses on two HIV self-testing service models. The first; is the online self-testing model (HIV self-testing conventional model) with the sexual health promotion network platform. The other one is an innovative HIV self-testing model (secondary distribution model), based on the previous program. The two different self-testing models, including the number of indexes and alters, the positive rate, and the demographics of indexes and alters, are compared. The influence of volunteers with or without leadership on the number of HIV self-test kits distributed or self-use is analyzed through the leadership survey scale.Results:The return rates of HIV self-testing results in the two models are 94.7%(323/341) and 99.2%(1 141/1 150), respectively, within 30 days. The proportion of alters in the secondary distribution is significantly higher (45.9%,281/612) than the conventional HIV self-testing (6.3%,20/318). In the secondary distribution model, the difference between the number of indexes and alters indicators including age, marital status, residence, sex orientation, anal sex with men in the past six months, and HIV test are statistically significant ( χ 2 test, all P<0.05). The opinion leader of MSM has significantly impacted the promotion of HIV self-testing ( P<0.05). Conclusions:Both models can promote HIV self-testing, result return, and HIV positive detection among MSM. In terms of expanding the testing and detection of HIV positive, the secondary distribution mode shows more obvious advantages, which significantly promotes a large number of MSM who have never been tested for HIV to undergo HIV testing. Influential indexes have a significant effect on increasing the HIV testing rate and promoting HIV testing among MSM.

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